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    Oren Livnat • H.C. Wainwright

    Oren Livnat's questions to Zevra Therapeutics Inc (ZVRA) leadership

    Oren Livnat's questions to Zevra Therapeutics Inc (ZVRA) leadership • Q4 2024

    Question

    Oren Livnat asked for a characterization of the initial bolus of MIPLYFFA patient referrals, an update on reimbursement approval rates for the 109 enrollments, more color on payer conversations, and the expected average net revenue per patient.

    Answer

    CCO Joshua Schafer clarified that of the first 90 enrollments, 69 were from the EAP. He noted that reimbursement rates are improving, with most patients gaining access via direct formulary coverage or the medical exception process. He described payer conversations as focused on clinical benefits. CFO R. Clifton stated that while specific gross-to-net details would not be shared, he does not expect the company to be aggressive with discounting.

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    Oren Livnat's questions to Zevra Therapeutics Inc (ZVRA) leadership • Q3 2024

    Question

    Oren Livnat asked about Zevra's plans for providing 2025 sales guidance for MIPLYFFA, the level of market awareness outside the EAP, whether the current SG&A expense is a good run-rate, and the status of OLPRUVA's patient numbers and revenue outlook.

    Answer

    President and CEO Neil McFarlane confirmed there are no plans to provide sales guidance in the early launch phase. Chief Commercial Officer Joshua Schafer noted that awareness is high due to strong patient advocacy relationships and sales force overlap. CFO LaDuane Clifton clarified that Q3 SG&A reflects the full commercial infrastructure but was inflated by a one-time $2.5 million stock compensation charge. Regarding OLPRUVA, Joshua Schafer confirmed active patients remain on therapy but did not provide numbers, suggesting revenue will remain de minimis until their refined strategy gains traction.

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    Oren Livnat's questions to Xeris Biopharma Holdings Inc (XERS) leadership

    Oren Livnat's questions to Xeris Biopharma Holdings Inc (XERS) leadership • Q4 2024

    Question

    Oren Livnat sought clarification on Recorlev's growth outlook, asking if it referred to percentage growth rates or absolute patient additions. He also questioned potential changes in market access, the status of FDA discussions for XP-8121, the possibility of achieving cash flow breakeven in 2025, and expected Q1 seasonality for Recorlev.

    Answer

    CFO Steven Pieper clarified that Recorlev's growth should be viewed in terms of absolute patient additions, given the larger base. CEO John Shannon confirmed no changes in reimbursement and stated that FDA dialogue for XP-8121 is ongoing. Pieper declined to guide on cash flow, emphasizing the focus on P&L strength and positive adjusted EBITDA. Shannon acknowledged typical Q1 payer resets would cause a slight slowdown for Recorlev before a rebound.

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    Oren Livnat's questions to Xeris Biopharma Holdings Inc (XERS) leadership • Q3 2024

    Question

    Oren Livnat asked for details on Recorlev's growth drivers, including dose and gross-to-net dynamics, and the patient mix between new and switch patients. He also questioned what it would take for the Gvoke market to accelerate and what level of detail to expect in 2025 guidance.

    Answer

    CEO John Shannon emphasized that Recorlev's growth is primarily driven by a rapid increase in new patient starts, not changes in dose or payer dynamics. For Gvoke, he stated that Xeris is driving all market growth and will continue to do so. He also confirmed that the company will provide more and different metrics in its 2025 guidance to better reflect the business's value creation.

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    Oren Livnat's questions to Avadel Pharmaceuticals PLC (AVDL) leadership

    Oren Livnat's questions to Avadel Pharmaceuticals PLC (AVDL) leadership • Q4 2024

    Question

    Oren Livnat of H.C. Wainwright inquired about the messaging for switching patients from Xywav, particularly regarding their tenure on the therapy, and asked about hurdles such as insurance coverage. He also sought an update on the expected timing for rulings on the pending injunction appeal and the royalty determination litigation.

    Answer

    Executive Gregory Divis stated that LUMRYZ has over 90% commercial coverage, comparable to competitors, and that perceived access issues are manageable objections. He noted that switch patients come from diverse backgrounds, not just one specific demographic. Executive Thomas McHugh provided litigation timelines, expecting a ruling on the injunction appeal within 2-3 months of the February 7th hearing and confirming the royalty determination ruling is still pending.

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    Oren Livnat's questions to Avadel Pharmaceuticals PLC (AVDL) leadership • Q3 2024

    Question

    Oren Livnat asked for details on the higher discontinuation rates among new-to-oxybate patients, the role of RYZUP support services, potential reimbursement hurdles like reauthorizations, expected formulary changes in 2025, and the current annualized net value per patient.

    Answer

    Executive Richard Kim attributed higher discontinuation rates in new patients to a lack of familiarity with oxybate therapy, emphasizing the need for RYZUP nurse navigators to manage expectations on dosing and tolerability. CEO Gregory Divis added that support is now more tailored by patient type. CFO Thomas McHugh confirmed the average annualized net revenue per patient is approximately $100,000, which includes patients receiving free drug.

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    Oren Livnat's questions to ANI Pharmaceuticals Inc (ANIP) leadership

    Oren Livnat's questions to ANI Pharmaceuticals Inc (ANIP) leadership • Q4 2024

    Question

    Oren Livnat from H.C. Wainwright asked for clarity on the ILUVIEN and YUTIQ transition, questioning if YUTIQ would be permanently discontinued and how potential timing, training, or cost differences might disrupt physicians. He also inquired about the importance of the Cortrophin prefilled syringe launch and its potential impact on net price.

    Answer

    Executive Nikhil Lalwani clarified the plan is to consolidate both indications under the ILUVIEN brand, which simplifies processes for physicians. He stated the transition is well-planned with inventory build-up and that the procedure and pricing are not materially different. Regarding the prefilled syringe, he positioned it as a convenience-enhancing option for patients that should help drive overall market growth, rather than impacting price.

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    Oren Livnat's questions to Pacira Biosciences Inc (PCRX) leadership

    Oren Livnat's questions to Pacira Biosciences Inc (PCRX) leadership • Q4 2024

    Question

    Oren Livnat asked about the assumptions behind the NOPAIN Act uptake, seeking to understand potential impediments to rapid adoption and any early evidence of successful reimbursement. He also questioned the company's capital allocation strategy, asking why Pacira isn't more aggressive with share buybacks given its confidence in EXPAREL's intellectual property. In a follow-up, he inquired about the drivers for the 2025 gross margin guidance.

    Answer

    CEO Frank Lee explained that NOPAIN uptake will take time as customers build awareness and test the new J-code, projecting a more meaningful ramp in the second half of the year. He noted encouraging early signs of reimbursement and commercial payer wins. Regarding capital allocation, Lee emphasized a disciplined, balanced approach to funding operations, advancing the pipeline like GQ Bio, managing debt, and utilizing the existing $125 million buyback authorization. CFO Shawn Cross and CEO Frank Lee addressed gross margins, noting potential quarter-to-quarter variability but expecting improvement over time with increased sales volume.

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    Oren Livnat's questions to Pacira Biosciences Inc (PCRX) leadership • Q3 2024

    Question

    Oren Livnat asked about the expected timeline for customer implementation of the NOPAIN Act and Pacira's readiness, as well as the long-term outlook for the legislation following the recent election.

    Answer

    CEO Frank Lee stated that while Pacira is prepared, he expects it will take time for customers to implement the new reimbursement, anticipating a more significant impact in the second half of 2025 and beyond. He expressed confidence in the long-term viability of NOPAIN, citing the strong bipartisan support it received, and believes this support will continue due to the ongoing opioid crisis.

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    Oren Livnat's questions to Tarsus Pharmaceuticals Inc (TARS) leadership

    Oren Livnat's questions to Tarsus Pharmaceuticals Inc (TARS) leadership • Q4 2024

    Question

    Oren Livnat asked for clarification on the 'on-demand' use case for the TP-05 Lyme disease therapy. He also questioned a potential Q4 channel stocking for XDEMVY, the incremental nature of the Q1 DTC spend, and retreatment rates among early adopters.

    Answer

    An executive explained that TP-05 is considered 'on-demand' because it is rapidly absorbed and provides protection within hours, making it suitable for prophylactic use. Chief Financial Officer Jeff Farrow confirmed there was no significant Q4 channel stocking, with inventory stable at ~2.5 weeks. He clarified the Q1 DTC spend of $15M is incremental to the ~$8M spent in Q4. He also reiterated the overall mid-single-digit retreatment rate, noting the 20% long-term target is based on clinical trial data.

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    Oren Livnat's questions to Tarsus Pharmaceuticals Inc (TARS) leadership • Q3 2024

    Question

    Oren Livnat of H.C. Wainwright & Co. asked for an explanation of the quarter-over-quarter decrease in SG&A expenses despite the sales force expansion and inquired about the company's early thoughts on potential pricing for XDEMVY in the European market.

    Answer

    CEO Bobak Azamian attributed the flat SG&A to the timing of the sales force onboarding (starting in September), offset by other general sales and marketing costs, and noted that SG&A is expected to increase in Q4. Chief Commercial Officer Aziz Mottiwala stated that while the European market has a significant need, work is ongoing to understand the country-specific reimbursement dynamics, emphasizing XDEMVY's unique value proposition.

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    Oren Livnat's questions to Collegium Pharmaceutical Inc (COLL) leadership

    Oren Livnat's questions to Collegium Pharmaceutical Inc (COLL) leadership • Q3 2024

    Question

    Oren Livnat of H.C. Wainwright & Co. asked about the appointment of Vikram Karnani as CEO, questioning the fit of his rare disease background with Collegium's mass-market portfolio. He also asked if Jornay PM's growth could accelerate post-transition, how it differentiates from other branded ADHD drugs, and a housekeeping question about product inventory levels during the quarter.

    Answer

    Executive Michael Heffernan defended the CEO choice, highlighting Vikram Karnani's transferable skills from leading Horizon Therapeutics' massive growth. Executive Scott Dreyer confirmed Jornay PM's growth (31.2% Y/Y) was strong through the transition and sees future acceleration from targeted investments and raising patient awareness. He noted physicians view Jornay's evening dosing as uniquely differentiated. Executive Colleen Tupper added that product inventory was stable, with only Jornay PM slightly lower than normal due to legacy ordering patterns.

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